MAUDE Adverse Event Report: MEDTRONIC IRELAND HAWKONE 6FR; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number H1-M

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/23/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was attempting to use hawkone directional atherectomy along with non-medtronic 6fr sheath and 0.014" guidewire during procedure to treat a none calcified soft tissue in the superficial femoral artery (sfa) with 80% stenosis.The vessel diameter and lesion length are 5mm and 40mm respectively.The vessel was not pre dilated but post dilated.Ifu was followed.It was reported that during withdrawal severe resistance was felt and the tip detached with the tip separated at the hinge pin.It was reported that physician has used hawk for many years.Physician was unable to close the cutter.It would not go into nosecone.This was at the very end, device was not very full and only made a few passes.Once he could not advance the cutter closed, he started to take out, but the hawk got stuck in the sheath and had to pull to get it out, it was at this point that the tip separated.The valve was removed from the sheath and was able to remove the hawk, completed the case and procedure was a success.Cutter was inside the housing unit while being removed from patient.No intervention required to remove detached tip.No deformation noted on cutter.No vessel damage noted.There was no patient injury.

Manufacturer Narrative

Device evaluation a visual inspection of the as received device shows that the housing/tip has detached distal to the anchor pockets and not at the hinge pins as reported.Due to the condition of the returned device no functional testing could be carried out.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HAWKONE 6FR
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11639817
• MDR Text Key: 258713656
• Report Number: 9612164-2021-01377
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968332
• UDI-Public: 00643169968332
• Combination Product (y/n): N
• PMA/PMN Number: K161361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2023
• Device Model Number: H1-M
• Device Catalogue Number: H1-M
• Device Lot Number: 0010461055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1